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Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert)

CPSC · 21729 · published 2021-03-18

CPSC campaign 21729

Hazard

The bottles containing the prescription drug can leak due to a fit issue between the press-in bottle adapter and bottleneck. If the bottle is leaking, there is a risk of drug exposure by contact with skin or eyes. Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents as required by the Poison Prevention Packaging Act (PPPA).

Remedy

Consumers should immediately store Evrysdi in a safe location out of reach and sight of children. Consumers should inspect the bottle for any leaking. If it is leaking, contact Genentech for a free replacement. Consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water. Genentech is contacting all known purchasers directly.

The text above is quoted verbatim from the CPSC record. Confirm the affected units and the remedy with the manufacturer or CPSC. Recall data may be incomplete, delayed, or superseded.

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Affected products

Genentech, a member of the Roche Group, of South San Francisco, Calif.

Evrysdi™ (risdiplam)

Brands in this recall